Both traumatic spinal cord injury and chronic compressive pathologies such as degenerative cervical myelopathy are poorly understood conditions that pose major healthcare challenges. To address the substantial knowledge gaps regarding the optimal treatment of these pathologies, AOSpine North America and International, in collaboration with the Cervical Spine Research Society and the American Association and Congress of Neurological Surgeons, sought to develop clinical practice guidelines on best practices for management of traumatic spinal cord injury and degenerative cervical myelopathy, as well as to address existing areas of controversy regarding treatment of these conditions.
“The two most topical areas of the guidelines relate to the role of timing for surgical decompression and the use of methylprednisolone for traumatic spinal cord injury,” explained Michael G. Fehlings, MD, PhD, FRCSC, FACS, Professor of Neurosurgery and Co-Director of the Spine Program at the University of Toronto in Ontario, Canada, and Chair of the AOSpine International Spinal Cord Injury Knowledge Forum.
Regarding the timing of surgical decompression, “We are trying to promote the concept that ‘time is spine’, with early surgery playing a key role in limiting the severity of the injury and enhancing recovery,” Dr. Fehlings said.
The use of methylprednisolone is a controversial topic, Dr. Fehlings noted, and it was felt that the AOSpine could objectively navigate this controversy by bringing together an international multidisciplinary group to examine current evidence.
The guidelines group formulated recommendations based on methodology proposed by the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) Working Group.
“The GRADE approach involves a two-step process,” Dr. Fehlings explained. “The first is a rigorous, systematic review of the literature, and the second is development of multidisciplinary guidelines. While these two processes are published independently, both are linked because the systematic reviews inform the guidelines’ process.”
“For the systematic review, we had the good fortune to collaborate with an excellent clinical epidemiology group called Spectrum Research,” Dr. Fehlings said.
Multidisciplinary Guideline Development Group
The multidisciplinary group included neurosurgeons, orthopaedic surgeons, physiatrists, neurologists, occupational therapists, radiologists, primary care physicians, nurses, patients, and representatives from nongovernment organizations that advocate for patients with spinal cord injuries. The group included a balance of gender, age, and seniority level, and members were required to have no significant financial or intellectual conflicts of interest.
To vet intellectual conflicts of interest, “we asked whether members would be open to reviewing and discussing the evidence with an open mind that might validate or challenge their position,” Dr. Fehlings told SpineUniverse. “It was an extremely healthy process and lead to fairly animated discussions, particularly on the topic of methylprednisolone.”
The GRADE approach describes the quality of evidence as high, moderate, low, or very low, based on the confidence that the observed effect sizes reflect the true effect. Thus, a randomized controlled trial (RCT) is considered strong evidence, and anything other than a RCT is considered weak evidence, Dr. Fehlings explained.
Next, the grading of a RCT can be lowered based on a number of factors that may weaken the quality of evidence. For non-RCTs, the level of evidence may be raised if, for example, the trial is prospective or if the effect sizes are large.
“This is where the methodologists play a significant role in determining the strength of the evidence,” Dr. Fehling said.
Guidelines Were Designed to Promote Shared Decision Making
“These guidelines distill, for the first time, existing evidence on these topics and aim to develop recommendations to outline how to manage patients with degenerative cervical myelopathy and traumatic spinal cord injury,” Dr. Fehlings said. “We hope these guidelines will promote shared decision making among physicians, patients and their families, standardize care worldwide and encourage future research to address existing knowledge gaps.”
Dr. Fehlings disclosed no relevant financial relationships.